Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol

Last updated: February 19, 2025
Sponsor: The Third People's Hospital of Hangzhou
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Pain (Pediatric)

Treatment

EA Group

Medication Group

EA+Medication Group

Clinical Study ID

NCT06261801
GZY-ZJ-KJ-23088
  • Ages 18-85
  • All Genders

Study Summary

Trigeminal herpetic neuralgia is a common type of Zoster-associated Pain (ZAP), which troubles individuals in all ages and burdens society all over the world. Eleactroaupuncture (EA) is increasingly used in the treatment of ZAP due to its advantages such as low price, high safety, no adverse reactions, and high patient acceptance. Therefore, it is necessary to conduct randomized controlled trials to evaluate the effectiveness and safety of EA on ZAP and whether EA can be used as a substitute for pregabalin.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. meet the aforementioned diagnostic criteria for trigeminal ZAP, with a diseaseduration of 1 to 3 months;

  2. have a visual analog scale (VAS) score of 4 points ≤ VAS ≤ 7 points;

  3. be between 18 and 85 years old, regardless of gender;

  4. have clear consciousness, the ability to distinguish pain, and complete basiccommunication;

  5. voluntarily participate in the study, sign a written informed consent form, andfully understand the plan.

Exclusion

Exclusion Criteria:

  1. do not meet the above-mentioned inclusion criteria;

  2. have concomitant herpes zoster on the trunk or extremities, or other special typesof herpes zoster like meningeal herpes zoster or visceral herpes zoster;

  3. are pregnant or lactating patients;

  4. are allergic to pregabalin or acupuncture stimulation;

  5. have severe organ damage, cognitive dysfunction, mental disorder, aphasia, or otherserious diseases that hinder cooperation with treatment;

  6. have severe skin diseases;

  7. have a pacemaker;

  8. have been or are currently participating in other clinical studies within the past 3months.

Study Design

Total Participants: 102
Treatment Group(s): 3
Primary Treatment: EA Group
Phase:
Study Start date:
February 07, 2024
Estimated Completion Date:
December 20, 2025

Study Description

Trigeminal herpetic neuralgia is a common type of Zoster-associated Pain (ZAP), which troubles individuals in all ages and burdens society all over the world. Eleactroaupuncture (EA) is increasingly used in the treatment of ZAP due to its advantages such as low price, high safety, no adverse reactions, and high patient acceptance. Therefore, it is necessary to conduct randomized controlled trials to evaluate the effectiveness and safety of EA on ZAP and whether EA can be used as a substitute for pregabalin.

Connect with a study center

  • The Hangzhou Third People's Hospital

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

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